Tag: Final Rule

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed […]

Final Medicare 60-Day Overpayment Rule Provides Reasonable Framework for Providers

Published today in the Federal Register was a long-awaited Final Rule implementing a requirement from the 2010 Affordable Care Act requiring Medicare Part A and B providers and suppliers to report and return overpayments to Medicare by the later of 60 days after the date an overpayment was identified, or the due date […]

CMS Exempts CME and Makes Other Sunshine Reporting Changes

Late last week, the Centers for Medicare and Medicaid Services (CMS) issued the 2015 physician payment fee schedule, which includes changes to the Final Rule implementing the federal Sunshine law.  Most significantly, CMS announced that it had exempted payments to speakers at all continuing medical education (CME) events under §403.904(i)(1) if the […]

A Few Good Nuggets Related to Sunshine at Industry Conference

Today at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF), the audience heard from Anita Griner, Deputy Director at the Centers for Medicare & Medicaid Services (CMS) who has responsibility related to Open Payments.  In addition to providing an overview of Sunshine implementation, Ms. Griner provided a […]

Final Rule Released on ACA’s Individual Shared Responsibility Payment

On August 27, 2013, the Internal Revenue Service (“IRS”) and the U.S. Department of Treasury (the “Treasury Department”) released a final rule, Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage, (the “Final Rule”), which was published in the Federal Register today, to implement the individual shared responsibility provision provided for under […]

TIME IS UP! Sunshine Data Tracking Starts Today

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly […]